Hot Water Immersion Therapy for Mental Health (WITHME)
Primary Purpose
Anxiety Disorders, Depression, Post-traumatic Stress Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
lower-limb hot water immersion
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorders
Eligibility Criteria
Inclusion Criteria:
- Over 18 years of age
- Diagnosed with depression, anxiety, or post-traumatic stress disorder
- Internet access (e.g. via smartphone, computer)
- Currently engaging in mental health treatment
Exclusion Criteria:
- Free of any mental health disorder
- Not engaging in regular mental health treatment
- Diagnosed with other psychiatric disorders (e.g. schizophrenia, bipolar disorder, panic disorder)
Sites / Locations
- Lakehead UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Sham Comparator
Active Comparator
Arm Label
Control
Lukewarm Water
Hot Water
Arm Description
Outcomes
Primary Outcome Measures
Change in Patient Health Questionnaire - 9 Item
Self-report measure of depression severity
Change in General Anxiety Disorder - 7 Item
Self-report measure of anxiety severity
Change in Post-Traumatic Stress Disorder Checklist - 20 Item
Self-report measure that assesses symptoms of PTSD
Secondary Outcome Measures
Post-water immersion thermal sensation
7-point scale to assess one's thermal state, with -3 defined as "Cold" and 3 defined as "Hot"
Post-water immersion thermal comfort
6-point scale to assess one's thermal satisfaction, with 1 and 6 defined as "very comfortable" and "very uncomfortable", respectively.
Post-water immersion thermal preference
5-point scale assessing whether the water temperature would be changed by the participant, with 2 defining 'much cooler' and -2 defining 'much warmer'
Full Information
NCT ID
NCT04793542
First Posted
March 4, 2021
Last Updated
March 8, 2021
Sponsor
Lakehead University
Collaborators
Northern Ontario School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04793542
Brief Title
Hot Water Immersion Therapy for Mental Health
Acronym
WITHME
Official Title
Evaluating Whether Lower-limb Hot Water Immersion Therapy Can Improve Symptoms in Individuals Diagnosed With Depression, Anxiety, and Post-traumatic Stress Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2021 (Anticipated)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
March 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lakehead University
Collaborators
Northern Ontario School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In 2016, it was estimated that nearly 1 billion people worldwide were affected by a mental or addictive disorder, and were associated with considerable excess mortality. Acute heat therapy sessions (e.g. whole-body heating or foot immersions) have been shown to improve symptoms in individuals diagnosed with common mental health illness such as major depressive disorders and reduce anxiety.
This study will assess the impact of an at-home 8-week lower-limb immersion in hot water on symptom severity in patients diagnosed with major depressive disorder, generalized anxiety disorder, and PTSD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depression, Post-traumatic Stress Disorder, Heat, Water Immersion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Lukewarm Water
Arm Type
Sham Comparator
Arm Title
Hot Water
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
lower-limb hot water immersion
Intervention Description
For a minimum of 30 minutes, 3 times a week for 8 consecutive weeks, participants will submerge their lower-limbs into 30-32°C (lukewarm) or 39-40°C (hot) water which will be measured with a supplied waterproof thermometer.
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire - 9 Item
Description
Self-report measure of depression severity
Time Frame
Change from baseline at 8 weeks
Title
Change in General Anxiety Disorder - 7 Item
Description
Self-report measure of anxiety severity
Time Frame
Change from baseline at 8 weeks
Title
Change in Post-Traumatic Stress Disorder Checklist - 20 Item
Description
Self-report measure that assesses symptoms of PTSD
Time Frame
Change from baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Post-water immersion thermal sensation
Description
7-point scale to assess one's thermal state, with -3 defined as "Cold" and 3 defined as "Hot"
Time Frame
throughout study completion, 8 weeks in duration
Title
Post-water immersion thermal comfort
Description
6-point scale to assess one's thermal satisfaction, with 1 and 6 defined as "very comfortable" and "very uncomfortable", respectively.
Time Frame
throughout study completion, 8 weeks in duration
Title
Post-water immersion thermal preference
Description
5-point scale assessing whether the water temperature would be changed by the participant, with 2 defining 'much cooler' and -2 defining 'much warmer'
Time Frame
throughout study completion, 8 weeks in duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 18 years of age
Diagnosed with depression, anxiety, or post-traumatic stress disorder
Internet access (e.g. via smartphone, computer)
Currently engaging in mental health treatment
Exclusion Criteria:
Free of any mental health disorder
Not engaging in regular mental health treatment
Diagnosed with other psychiatric disorders (e.g. schizophrenia, bipolar disorder, panic disorder)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas Ravanelli, PhD
Phone
1 (807) 343-8544
Email
nravanel@lakeheadu.ca
Facility Information:
Facility Name
Lakehead University
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 5E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Ravanelli, PhD
Phone
1 (807) 343-8544
Email
nravanel@lakeheadu.ca
First Name & Middle Initial & Last Name & Degree
Diane Whitney, Dr.
First Name & Middle Initial & Last Name & Degree
Sarah Habinski, Dr.
12. IPD Sharing Statement
Learn more about this trial
Hot Water Immersion Therapy for Mental Health
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